510(k) · Cleared
ClearedIVENT101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Versamed Medical Systems, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Mar 16, 2009 as substantially equivalent to K060647 (Pulmonetic Systems, Inc., 2006) and 3 other predicates after a 259-day review. Its family tree reaches back 9 generations to 1991. 5 of the 67 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 16, 2009
- Review
- 259 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K902859 (1991). 66 ancestors in all, the oldest K841279 (1984). No later device cites it as a predicate yet. 5 of the 67 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations between
- 3 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 2 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- This deviceK081845 IVENT101Versamed Medical Systems, Inc. · 2009
Show all 9 generations
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 7 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 6 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 5 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 4 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 3 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 2 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- This deviceK081845 IVENT101Versamed Medical Systems, Inc. · 2009
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −8 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −7 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −6 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −5 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −4 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −3 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −2 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −1 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| 0 (this device) | K081845 | IVENT101 | Versamed Medical Systems, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 9 | 2 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 1 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060647 | LTV 1200 VentilatorSummary page 3…S78 Predicate Devices: The iVentlO1is substantially equivalent to: · LTV1200 cleared under K060647 * iVent201 cleared under K061627 * PLV Continuum II cleared under K034032 * Legendair XL2 cleared under K… | 2006 |
| * | K061627 | Modification to I Vent 201Summary page 3…S78 Predicate Devices: The iVentlO1is substantially equivalent to: · LTV1200 cleared under K060647 * iVent201 cleared under K061627 * PLV Continuum II cleared under K034032 * Legendair XL2 cleared under K070899 Substantial Equivalence and Tech… | 2006 |
| * | K034032 | PLV Continuum Ventilator, Model P2000Summary page 3…The iVentlO1is substantially equivalent to: · LTV1200 cleared under K060647 * iVent201 cleared under K061627 * PLV Continuum II cleared under K034032 * Legendair XL2 cleared under K070899 Substantial Equivalence and Technological Characteristics: The iVentlOl is… | 2004 |
| * | K070899 | Puritan Bennett Legendair XL2Summary page 3…· LTV1200 cleared under K060647 * iVent201 cleared under K061627 * PLV Continuum II cleared under K034032 * Legendair XL2 cleared under K070899 Substantial Equivalence and Technological Characteristics: The iVentlOl is viewed as substantially equivalent to the fol… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett · 2007 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 18 of the 66 ancestors have a recall of any class; 5 have a Class I recall.
- 8 other devices also cite its predicate K060647.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive…
Read the full statement (110 words)
The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities:
Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated Volume Control (PRVC)
(CPAP with Pressure Support
Adaptive Bi-Level for either NIV or invasive ventilation.
The iVentI 01 ventilator is suitable for use in institution, home and portable settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081845 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081845: IVENT101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081845
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026